Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Digestive Illness Clinical Trial

Official title:

Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153084
• Other study ID #: FIS-POL-2017-01
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Alejandro Rodríguez Martínez
• Phone: 955012000
• Email: alejandro.rodriguez.m.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 31, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• From 1 to 16 years old.

• Patients that signed the informed consent form.

Exclusion Criteria:

• Urgent colonoscopy

• History of intestinal resection

• Nephropathy, heart disease or metabolic syndrome.

Related Conditions & MeSH terms

• Digestive Illness

Intervention

Drug:
• Polyethylene Glycol 4000 with electrolytes
The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
• PEG-3350 with electrolytes
The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
• Sodium picosulfate
The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age: From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h) From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Torrecárdenas	Almería
Spain	Hospital Materno-Infantil de Badajoz	Badajoz
Spain	Hospital Universitario Puerta del Mar	Cadiz	Cádiz
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Instituto Hispalense de Pediatría	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale	The quality of the preparations will be measured using the Boston Bowel Preparation Scale (BBPS), semiquantitative evaluation of the cleanliness of the three colon sections (left, transverse, right) using a score from 0 to 3, giving a total score of 0 (without preparation) to 9 (optimal) and it´s done by two independent observers.	From November 2018 to December 2019
Secondary	Evaluate the acceptance of the different preparations.	The acceptance will be measured using a questionnaire and a quantity record, the questonnaire is made by three items: flavour, odour and volume while the quantity record measures the quantity of preparation ingested by the participant.	From November 2018 to December 2019
Secondary	Evaluate the tolerance of the different preparations.	The tolerance will be measured using a questionnaire and a symptoms record, with a score from 0 (terrible tolerance) to 3 (good tolerance) for each of its items, that are the following: abdominal pain, nausea and vomit, intestinal noises, abdominal distension, burps, flatulences, urgent bowel movements and tenesmus.	From November 2018 to December 2019
Secondary	Evaluate the security of the different preparations.	The security will be measured analysing the existence of adverse effects due to the different preparations.	From November 2018 to December 2019